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Certificate of Analysis
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QA: Sharon Lee
QC:
Paulo Park
Date:
Mar. 28, 2014
CAS 30484-77-6 Batch No. B2014Y0326
Product Name Flunarizine Dihydrochloride Quantity 165.20kg
MFG. Date Mar. 26, 2014 Retest Date Mar. 25, 2016
TESTING ITEM SPECIFICATION RESULT
Appearance White or almost white powder White powder
Melting Point About 208°C,
with decomposition 209~210°C,
with decomposition
Identification
1) IR: The IR absorption spec-trum of sample
corresponds to that of the ref-erence one.
2) It shows the reaction of Chloride.
Complies
Loss on Drying NMT 5.0% 0.2%
Residue on Ignition NMT 0.1% 0.02%
Impurity A NMT 0.1% Not Detected
Impurity B NMT 0.5% 0.10%
Impurity C NMT 0.25% 0.07%
Impurity D NMT 0.1% 0.05%
Any other impurity NMT 0.1% 0.06%
Total impurities NMT 1.0% 0.32%
Assay 99.0%~101.5% (Calculated on
dried basis) 100.4%
Conclusion Complies with EP 7.0
Flunarizine Dihydrochloride
